MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER LEGION SYSTEM; UNIT, PHACOFRAGMENTATION

Catalog Number 8065753075

Device Problem Suction Failure (4039)

Patient Problems Corneal Edema (1791); Visual Disturbances (2140)

Event Date 10/05/2021

Event Type  Injury  

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported that an ophthalmic operating console presented aspiration failure during a cataract surgery.The surgery was completed successfully.The patient experienced post-operative corneal edema with low visual acuity.The patient required unspecified medical intervention.Additional information has been requested but none received.

Manufacturer Narrative

The initial decision to report was incorrect resulting in the initial report being submitted in error.This report does not meet criteria for reporting as a device malfunction or a serious injury.No further reports will be reported under mfg report num.2028159-2021-01262.The manufacturer internal reference number is: (b)(4).

• Brand Name: LEGION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 12728816
• MDR Text Key: 279313135
• Report Number: 2028159-2021-01262
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: TBD
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065753075
• Device Lot Number: 13R7XH
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention